Persistent Supplement Fraud Prompts Online FDA Warnings for Consumers

Persistent encounters
of supplement fraud from illegally spiked products has prompted the Food and
Drug Administration (FDA) and industry associations to post website warnings of
health hazards, including death, associated with some dietary supplements.

Tainted products
that contain hidden drugs and other dangerous substances are marketed by
unscrupulous manufacturers who willfully ignore industry regulations and the
safety of users. Consumers for arthritis, weight loss, body building, sexual
enhancement, and other issues are targeted most often.1,2

An FDA
supplement fraud webpage, Tainted Arthritis/Pain Products provides public notification
links to nine arthritis supplement recalls between August 22, 2013 and October
30, 2017 for containing dangerous hidden pharmaceuticals. When accessed, the most recent involved the
dietary supplement, Double Caulis Plus,
promoted for joint, gout and back pain.
An FDA laboratory analysis confirmed it contained dexamethasone, a
corticosteroid commonly used to treat inflammatory conditions. As part of the warning, the FDA outlined side
effects from the drug and urged unsuspecting consumers to consult a physician
for supervised withdrawal from use. 3,4

FDA: Beware of tainted dietary supplement fraud

Fraudulent supplements have captured the
attention of federal regulators because of their public safety issues. The FDA
site Beware of Fraudulent Dietary
Supplements warns consumers that tainted products being marketed as dietary
supplements actually contain hidden or deceptively labeled ingredients, such
as:

The
active ingredients in FDA-approved drugs or their analogs (closely-related
drugs).

Other
compounds, such as novel synthetic steroids, that do not qualify as dietary
ingredients.

“These products are
masquerading as dietary supplements—they may look like dietary supplements, but
they are not legal dietary supplements,” says Michael Levy, director of FDA’s
Division of New Drugs and Labeling Compliance. “Some of these products contain
hidden prescription ingredients at levels much higher than those found in an
approved drug product and are dangerous.”2

FDA has received numerous reports of harm from
supplement fraud associated with the use of these products, including stroke,
liver injury, kidney failure, heart palpitations, and death.

In addition to arthritis, rheumatoid arthritis
and gout, fake supplements spiked with pharmaceuticals are promoted most often
for weight loss, sexual enhancement, and bodybuilding, according to the FDA.

“We need consumers to be aware of these
dangerous products and learn how to identify and avoid them,” says Levy.2

FDA 101: Supplement fraudsters make unsupported drug claims

Supplement fraud is also the deceptive sale or
advertising of products that claim to be effective against medical conditions
or otherwise beneficial to health, but which have not been proven safe and
effective for those purposes, according to the webpage, FDA 101: Health Fraud Awareness.5

On this awareness page, the FDA refers to supplement fraud as “health scams”, which it says wastes billions of consumer dollars each year and can lead patients to delay proper treatment and cause serious—even fatal—injuries.

“Since the 1990s, peddlers of fraudulent ‘health’ products have used the Internet as a primary tool to hawk their wares. This has kept the FDA and other agencies busier than ever in protecting the public from health fraud,” the FDA said.

In addition to arthritis, other common types of health fraud include cancer, HIV/AIDS, weight loss, sexual enhancement, body building and diabetes, according to the FDA Health Fraud Awareness page.5

When supplements that claim to treat disease are not documented sufficiently by clinical studies, the FDA considers them to be drugs for making claims that only an approved pharmaceutical can make. The agency labels these products as bogus dietary supplements.

Supplement fraud occurs because FDA doesn’t approve pre-market

Dietary supplements, in general, are not
FDA-approved. Under the Dietary Supplement Health and Education Act (DSHEA) of
1994, dietary supplement firms do not need FDA approval prior to marketing
their products. It is the company’s responsibility to make sure its products
are safe and that any claims are true. 6,7

Manufacturers and distributors of dietary
supplements and dietary ingredients are prohibited by regulation from marketing
products that are adulterated or misbranded.
That means that these firms are responsible for evaluating the safety
and labeling of their products before marketing to ensure that they meet all
the requirements of the DSHEA, including its counterpart, the current Good Manufacturing Practices (cGMP) rules. FDA is responsible for initiating
corrective action against any adulterated or misbranded dietary supplement
product after it reaches the market.
6,7

For example, an
arthritis supplement on a store shelf or sold on a website does NOT mean it is safe or effective,
according to the FDA. When safety issues are suspected, FDA must investigate
and, when warranted, take steps to have the product removed from the market.
However, it is much easier for a firm to get a product on the market than it is
for FDA to take a product off the market. 2

The FDA does not
analyze dietary supplements for arthritis, rheumatoid arthritis, gout or any
other purpose, before they are sold to consumers—they never even see the
finished product. The FDA says it “has
limited resources to analyze the composition of dietary supplements” through
spot checks of products for sale.7

While the FDA is aware
that fraudulent supplements exist on the market currently, it “focuses
resources first on public health emergencies and products that may have caused
injury or illness. Enforcement
priorities then go to products thought to be unsafe or fraudulent or in
violation of the law. The remaining
funds are used for routine monitoring of products pulled from store shelves or
collected during facilities inspections of manufacturing firms.”7

Industry associations are concerned about “blatant” criminal activity

Leading
trade associations from the dietary supplement industry and the U.S.
Anti-Doping Agency (USADA) jointly expressed support of the October 31, 2017
warning against using illegal Selective Androgen Receptor Modulators (SARMs) in
sports nutrition products marketed for body-building, according to the Council for Responsible Nutrition.1

The Natural Products Association (NPA), along with five other dietary supplement trade associations, authored a news release December 3, 2015 in support of reorganization within the FDA to help increase the agency’s abilities to take more aggressive enforcement of perpetrators of supplement fraud.

The trade associations also expressed their concern over “blatant” criminal activity in the supplement industry and that elevating the Division of Dietary Supplement Programs (DDSP) to an official FDA Office would help increase FDA’s visibility and attention for supplement safety and compliance measures. The NPA represents the entire natural products industry 8

Speakers from the
FDA’s Division of Drug Information (DDI) Webinar Series stressed that fraudulent supplements when discovered to contain hidden pharmaceutical drugs, lose their classification as 'dietary supplements', according the article by Steve Myers in Natural Products Insider, November 21,
2017. 9

The webinar was aimed
at current and prospective doctors, nurses and pharmacists. “’Tainted
supplements’ is not the correct term for products adulterated with active
pharmaceutical ingredients (APIs),” said one of the speakers, Capt. Jason
Humbert, R.N., national health fraud coordinator in FDA’s Office of Regulatory
Affairs. “These are not considered
dietary supplements, but drugs pretending to be dietary supplements,”. he
noted, while adding the practice of selling tainted products “defies logic.”

The list of
adulterants found in various supplement fraud categories can range from bodybuilding
compounds (e.g. anabolic steroids, analogues, aromatase inhibitors),
prescription drugs, corticosteroids and banned/illicit drugs, according to the
article.

The webinar also
featured Nicole Kornspan, M.Ph., consumer safety officer at FDA, who said while
weight-loss, bodybuilding and sexual enhancement products top the list of
supplement fraud, “adulteration crosses many health targets, including
arthritis, diabetes, chronic pain, hypertension, high cholesterol and
hypothyroidism.”9

When the FDA does catch
a company peddling tainted products, a class 1 recall is almost always
issued. Many supplement recalls involve arthritis-related products. These are
termed voluntary recalls requested by the FDA, which then oversees the recall
strategy and implementation. “We hardly
ever, if never, receive or are notified by a firm selling tainted products that
‘I just realize my products are tainted and I need to recall those;’ instead
this is the agency approaching the firm to conduct a voluntary recall,” Humbert
was quoted in the article.9

Settlement against glucosamine supplement Osteo Bi-Flex and others

The glucosamine market over the past decade has
exhibited steady growth globally, driven by a growing aging population, and
promotions by companies regarding the health benefits of glucosamine as a vital
dietary supplement for joint health conditions like knee osteoarthritis. The
global market is expected to reach $1.2 billion by 2020, according to a study
by Grand View Research, Inc. 10

Supplement claims,
when not backed by conclusive clinical studies, are considered supplement
fraud. One large manufacturer is in
trouble with a group of class action plaintiffs.

The producer of the
popular joint health glucosamine supplement, Osteo Bi-Flex is under fire in a lawsuit alleging the company
committed supplement fraud by making exaggerated benefit claims about the
product. The suit has drug through the
court system for several years, but a preliminary second settlement was approved
by a Federal District Judge on February 1, 2017. The first agreement required the defendant to
pay a total of $5.6 million. The second
settlement to pay out a total of $9 million.11

The lawsuit was
brought against The Nature’s Bounty Company (NBTY), their subsidiary group
Rexall Sundown, Inc., and numerous major retailers including Target, Costco and
CVS. The brands and supplements
specifically listed in the court documents include Osteo Bi-FlexTriple Strength,
Flex-a-Min Triple Strength, Kirkland GlucosamineChondroitin, and CVS Triple Strength Glucosamine Chondroitin with MSM. Should the settlement move forward, several
dozen related brands will be affected 11

The defendant has
maintained the allegations aren’t true, however they agreed to remove key
statements on scores of brands and products.
For example, they stopped stating that the supplements help to repair
and/or build cartilage. According to
court documents, Rexall is barred from using the phrases “fixing, mending,
reconditioning, rehabilitation, increasing, developing, building, repairing,
rebuilding, renewing, re-growing, adding, regenerating or rejuvenating
cartilage.” Also prohibited from making
other types of structure/function claims, such as the covered products
“support, protect, or promote joint comfort, mobility, or health.”11

Fraudsters who add
active ingredients but deliberately hide them from labels to avoid detection
commit Dietary Supplement Fraud (DSF), which the FDA often classifies as
Economically Motivated Adulteration (EMA), according to comprehensive research,
Defining the Public Health Threat of Dietary Supplement Fraud, published November 2013 in the journal Food
Science & Food Safety.12

“Fraudsters spike supplements with illegal drugs or previously banned substances in order to increase effectiveness and therefore customer satisfaction with the finished products,” the lead author, Virginia Wheatley said. “But consumers remain unaware.”

The study concluded such operations are a direct threat to public health and further magnify the issue as unscrupulous owners continually evade regulatory hurdles and established quality controls.12

“Fraudsters are focused on taking advantage of regulatory loopholes for their own economic profit, but do not consider or do not care about the public health consequences of their activities,” the author wrote. “Savvy fraudsters took advantage of opportunities to promote health benefits without strict oversight of their marketing activities. As a result, misbranded and adulterated products reach consumers.”12.

The purpose of the research was to provide a comprehensive overview on the public health threat of DSF in response to adverse health events reported from adulterated supplements. Consumers experienced severe health effects, such as lowered blood pressure, kidney damage, heart-related complications, or have lost their lives, the study said, while calling for regulatory reform and consumer education.12

FDA and other groups warn against fraudulent body
building supplements

Leading trade
associations from the dietary supplement industry and the U.S. Anti-Doping
Agency (USADA) warned body-builder consumers about the risks of certain
supplements containing illegal drugs in an announcement on November 8,
2017. The groups jointly expressed
support of the FDA’s October 31, 2017 warning against using

“SARMs
are dangerous drugs and pose an immediate risk to consumers, jeopardize the
careers of athletes, and have no place in any sports nutrition regimen,” the
USADA said.14

The
FDA’s online brief said once a supplement is discovered to
contain SARMs, it becomes classified as an unapproved
drug and is no longer considered a dietary supplement. Unlike supplements, drugs must be reviewed by
the FDA for safety and effectiveness.15

The USADA
webpage, Vitamins, Minerals and Other
Supplements, warns that “while some mainstream supplements are made by
responsible manufacturers, a growing number of supplement products contain
dangerous and undisclosed ingredients, including steroids, stimulants, and
other dangerous drugs. It says that one
major issue is unscrupulous companies are marketing supplements spiked with
these substances, taking advantage of many consumers’ desires for maximized
sport performance or aesthetic improvements and advertising them as healthy and
safe when they’re not.” 16

The USADA says
“most Americans are unaware that designer steroids and other dangerous drugs
are intentionally being sold as dietary supplements and that current law makes
it too easy for these products to get to the market.” It further speculates, “Best estimates suggest
that there are hundreds of supplement
products currently available that contain one or more of approximately 20
to 25 designer steroids alone.” 16

Olympic athletes fail drug tests for using fraudulent supplements

The collateral damage
from fraudulent supplements extends to Olympic athletes who have suffered the
consequences of unknowingly consuming tainted dietary supplements, then being disqualified from competitions for doping.

American Jessica Hardy,
multiple swimming medal winner in the Olympics, tested positive from an
undisclosed dietary supplement substance and was banned from the 2008 U.S.
Olympic team. Another U.S. swimmer, Kicker Vencill, tested positive for small
amounts of 19-norandrosterone. Lab tests pointed to a contaminated
multivitamin.Pavle Jovanovic, a U.S. Olympic team bobsledder, was suspended for two
years in 2004 for testing positive for a banned substance that was undeclared
on labels of ten supplements he used the day he was tested.13

Stories of athlete’s
failed doping tests from use of dietary supplements that contain hidden banned
substances have been reported globally.
World-class athletes whose eligibility for competition includes drug
testing, receive frequent instruction about the hidden dangers from supplement
use.

Why U.S. Olympic athletes place trust in the supplement industry leader

Olympic and world
class athletes have the most stringent anti-doping regulations in sports. What they put into their bodies is critically
important to them. They cannot afford to be victims of supplement fraud. The guaranty of quality and purity is of
utmost importance for athletes to pass drug tests. Efficacy is also a necessity to ensure they
get the performance needed to compete at the highest level.

Many of these
elite athletes have chosen Shaklee Corporation in the U.S. for the nutritional
supplements that have powered them to winning a combined 121 gold, silver and bronze medals at the Summer
and Winter Games. They truly represent
the company’s long-time commitment to creating 100% safe, pure and effective
nutrition that gives athletes the healthy edge they need.

Shaklee
nutritional products have helped power seven of Time-Life Books “Greatest Adventures
of All Time.” They’ve helped
adventurers cross both the North and South Poles, explore the deepest depths of
the oceans, and fly non-stop around the planet without artificial propulsion.

Supplement seals cannot guarantee safety

Don’t be misled by
dietary supplement labels that contain words as “verified”, “certified,” or
“approved”. Such terms do not mean the
product has been tested by the FDA or is effective and safe, according to the
article, What ‘USP Verified’ and Other
Supplement Seals Mean, by Laurie Tarkan, in the September 2016 issue of Consumer Reports magazine.17

The United States
Pharmacopeia (USP) is a nonprofit compendium of drug information for physicians
and pharmacists. For dietary
supplements, the organization offers the “USP Verified” label seal, which is
perhaps more influential in the medical community than other supplement quality
seals, such as GMP, NSF International, National Products Association (NPA) and
ConsumerLab (CL).18,19

“No supplement seal
guarantees the safety or effectiveness of the ingredients in the bottle,”
Sharon Akabas, Ph.D., associate director of education initiatives at Columbia
University’s Institute of Human Nutrition, is quoted as saying.17

None of the
organizations guarantee the effectiveness of products, nor do their seals
guarantee purity. They do not test every
batch. In most instances the
manufacturer provides the product to be certified, followed by periodic follow
up tests the certifying organization purchases in stores.17,18,19

Instances of supplement
fraud could still occur, but dietary supplements containing such seals have a
high probability the product contains the amount of the ingredient advertised
on the label and that it isn’t contaminated with dangerous substances, such as
arsenic, bacteria, or lead, according to the article.

Of interest, the author
adds: “Manufacturers must pay to get their supplements tested and certified,
which may be a reason that only a tiny fraction of the 90,000 or so dietary
supplements on the market carry one of these seals. USP, for example, has verified only 139
products to date.” Consumers should
therefore be cautioned against forming any inappropriate conclusions about
companies that choose not to pay the fee and participate in such programs.17,18,19

One manufacturer far exceeds quality standards of the USP seal

Put supplement fraud in
your rear view mirror. One company does not need to buy seals
because it already more than doubles the USPs purity and quality standards. Science and innovation are at the heart of
the #1 natural nutrition company in
America, which conducts 350 tests of raw ingredients--220 more than the
standards established by the USP.

They produce the purest and best supplements because of their obsession with quality, . It’s one thing to say products are good, but another to prove they are effective through scientific studies conducted in collaboration with leading academic labs that are unrestricted and encouraged to publish their findings, whatever the results. The academics control publication of the findings, not our recommended company. This is very important.

To eliminate any doubt about supplement fraud,are your dietary supplements for arthritis or gout pain the best that money can buy? They may be, if they can answer YES to
the following questions:

Are they organic; or as our
recommended company explains, beyond organic?

Are their ingredients tested
for 350-plus contaminants?

Are they safe?

Are they supported by clinical
studies?

Are they tested for efficacy
prior to marketing to confirm effectiveness in the human body?

Are the contents accurately
listed on the product label?

Does the “per-serving milligrams”
encapsulated in the bottle confirm label claims in laboratory tests?

Surprisingly, for a large majority of dietary supplements on the market,
the answer to many of these questions is a resounding NO

From personal use we recommend one manufacturer that answers YES to each question, the Shaklee
Corporation. For arthritis relief, their pain trio of joint and muscle pain
relief products are extremely safe, tested and effective

Remarkably different from other supplement companies, they operate more
like a pharmaceutical manufacturer. They
won’t be caught in supplement fraud because the quality and science behind
their products are unmatched in the industry. They far exceed the cGMP’s for purity.

Only a tiny fraction of supplements for sale on
the U.S. market are backed by clinical studies to prove effectiveness. No matter what price you pay, you’re likely
throwing your money away without proof of clinical studies.

In business since 1956, this California-based leader is the gold standard
supplement company. When you purchase
the best joint health supplement there’s no disappointing ineffectiveness found in other supplements.

Their motto is The Golden Rule. They
are a company with a conscience. Their
mission is to make each of their products the best and safest that money can
buy. Period. Guaranteed.
And isn’t that what you want?

If you are looking for pure, safe arthritis pain
products that work, follow this "pain trio" (scroll linked page for My Arthritis Story) link. You’ll be glad you did. Avoid the possibility of supplement fraud. You’ll like the way your body feels when your
cells are nourished with the best supplements anywhere.

Supplement Fraud Disclaimer:
Health statements on this Supplement Fraud page have not been evaluated by the
Food and Drug Administration. These products are not intended to diagnose,
treat, cure, or prevent any disease

Major study proves safety and benefits of Shaklee users long-term The cross-sectional clinical study, Usage patterns, health, and nutritional status of long-term multiple dietary supplement users conducted by lead author Gladys Block and the University of California at Berkeley demonstrated the powerful effects of long-term use of multiple Shaklee Corporation dietary supplements for 20 years or more. Those users had healthier levels of many chronic disease-related biomarkers including HDL cholesterol, homocysteine, and C-reactive protein. The study was published in the Nutrition Journal October 24, 2007. For additional details, please click www.landmarkstudy.com

Health statements have not been evaluated by the Food & Drug Administration.
This site is not intended to diagnose, treat, cure, or prevent any disease.
Copyright 2008 Arthritis-Relief-Naturally.com
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